MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIXED CEMENTED SIZE 5

Model Number	02.07.1205L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 1 month after primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon removed all medacta hardware and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 25-mar-2025.Lot 2317433: (b)(4) items manufactured and released on 11-oct-2023.Expiration date: 25-sep-2028.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Additional items involved in the event, batch review performed on 25-mar-2025: gmk-sphere 02.12.0025l femoral component sphere cemented size 5+ l (k140826) lot.2341436 lot 2341436: (b)(4) items manufactured and released on 13-dec-2023.Expiration date: 26-nov-2028.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.E0511fl tibial insert fixed sphere flex size 5/11 mm l e-cross (k202022) lot.2337146.Lot 2337146: (b)(4) items manufactured and released on 19-sep-2023.Expiration date: 03-sep-2028.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Additional Manufacturer Narrative
Additional information received on 01.July.2025: on (b)(6) 2025 the patient came in due to a new infection.The surgeon performed a washout, removed all implants and put in new primary implants.The surgeon elected to do this because he observed that the bone quality was good and the ligaments were intact.The surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIXED CEMENTED SIZE 5
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21737985
• Report Number: 3005180920-2025-00287
• Device Sequence Number: 18299149
• Product Code: JWH
• UDI-Device Identifier: 07630030819926
• UDI-Public: 07630030819926
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.07.1205L
• Device Lot Number: 2317433
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown